Clinical Data Coordinator
$73.2k - $89.5kMadrigalpharma
- # Clinical Data CoordinatorApplylocations: PA - Conshohocken - Officetime type: Full timeposted on: Posted Yesterdayjob requisition id: JR\_000773Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH. Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c). Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To support our continued growth, we are strengthening our workforce strategy to ensure we have the right talent, at the right time, in the right way.The Clinical Data Coordinator is responsible for supporting the collection, management, and quality assurance of clinical trial data to ensure data integrity and regulatory compliance. This role works closely with Data Managers, Clinical Operations, Biostatistics, and external vendors to facilitate accurate and timely database delivery for Madrigal Pharmaceuticals’ clinical development programs. The Clinical Data Coordinator contributes to data entry tracking, query management, and data cleaning activities in alignment with Good Clinical Practice (GCP) and company standards.**Key Responsibilities** • Assist in the setup, maintenance, and closeout of clinical study databases across multiple phases of development. • Support Data Managers in ensuring data accuracy, completeness, and consistency throughout the clinical trial lifecycle. • Perform routine data entry checks, generate and track data queries, and ensure timely resolution in collaboration with site personnel and vendors. • Participate in the review and testing of electronic data capture (EDC) systems, case report forms (CRFs), and data validation specifications. • Track receipt and review of external data sources (e.g., laboratory, imaging, PK/PD, ECG, ePRO) to ensure timely integration and reconciliation. • Assist in the preparation of Data Management Plans (DMPs), edit check specifications, and data validation listings. • Maintain documentation of data cleaning activities, ensuring compliance with SOPs, GCP, and regulatory requirements. • Participate in data review meetings and contribute to database lock readiness activities. • Support audit and inspection preparation by ensuring documentation accuracy and traceability. • Perform other related duties as assigned in support of departmental and corporate goals.**Qualifications and Experience** • Bachelor’s degree in Life Sciences, Computer Science, or related field. • Minimum of 1–2 years of experience in clinical data management or a related clinical research role within the pharmaceutical or biotechnology industry. • Working knowledge of clinical trial processes and regulatory guidelines (GCP, ICH, FDA). • Experience with one or more electronic data capture (EDC) systems such as Medidata Rave, Oracle InForm, or Veeva CDMS. • Familiarity with clinical data standards (CDASH, SDTM) preferred. • Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint, Outlook). • Strong attention to detail and organizational skills. • Excellent written and verbal communication skills. • Ability to work collaboratively in a hybrid team environment and manage multiple priorities.**Preferred Experience** • Exposure to complex or adaptive clinical trial designs. • Experience supporting Phase II or III clinical trials. • Familiarity with data from external vendors (e.g., central labs, imaging, ECG, ePRO, PK/PD). • Experience in oncology, metabolic, or cardiovascular clinical trials preferred. • Prior involvement in data reconciliation, SAE reconciliation, or data review listings generation.**Core Competencies** • Quality Focus: Demonstrates a commitment to maintaining high data quality and accuracy. • Accountability: Takes ownership of assigned tasks and delivers results in a timely manner. • Collaboration: Works effectively with internal and external stakeholders in a team-oriented environment. • Adaptability: Responds positively to changing priorities and timelines in a dynamic research setting. • Integrity: Upholds ethical standards and maintains confidentiality of clinical data.Madrigal’s Total Rewards strategy is based on a biotech industry peer group comparator and is inclusive of base pay, bonus and equity. Our equity offers meaningful opportunity allowing our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization.All employees receive equity, which we believe reinforces our ownership culture. Base salary is determined by several factors including the candidate’s qualifications, skills, education, experience, business needs and market demands. As of the date of this posting, a good faith estimate of the current pay scale for this position, applicable to all candidates, is $73,200 - $89,500 per year. We comply with all applicable minimum wage laws.All full-time employees receive equity, which reinforces our ownership culture and offers meaningful opportunity for our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization. Full-time employees are also eligible for comprehensive benefits, including flexible paid time off, medical, dental, vision and life/disability insurance, and 401(k) offerings (i.e., traditional, Roth, and employer match) in accordance with applicable plans. We also offer additional voluntary benefits like supplemental life insurance, legal services, and other offerings. In addition, we offer mental health benefits through our Employee Assistance Program for employees and their family. The company also provides other benefits in accordance with applicable federal, state, and local laws. We are committed to providing reasonable accommodations for individuals with disabilities throughout the hiring process. If you need assistance, please contact View email address on click.appcast.io. Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law. Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established. Applications are being accepted on an ongoing basis and can be submitted through our Madrigal Careers site. *Please be aware that we have received reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals’ Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigal’s name and logo in an attempt to solicit up-front fees and obtain personal information from interested job candidates. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process.* *Please also note that any correspondence with regard to employment would come from an authorized madrigalpharma.com email address or from an email address from one of our trusted search firm partners. We are aware that incorrect/fraudulent email addresses, with Madrigal misspelled, have been utilized in these most recent fraud attempts. If you receive unsolicited employment offers from people claiming to work for or on behalf of Madrigal, we recommend that you: do not respond to their questions; do not open any attachments; and do not click on any hyperlinks. Any questions regarding the legitimacy of job-related contacts can be directed to* *View email address on click.appcast.io**.*
- J-18808-Ljbffr Madrigalpharma
Vacancy posted 6 days ago
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